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PFE FDA Decision Approved · 2025-02-12

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 2/12/25$30.19$24.88/28/24
Daily close, T-120 (8/28/24) through T+5. Run-up high $30.19 on 10/16/24, low $24.8 on 11/22/24 (T-120 to T-1). FDA decision 2/12/25. Historical price action, not a forecast.
Positioning before the decision
On Jan 29, 2025, 14 days before the decision date, at-the-money options priced a move of ±4.9% through Feb 14, 2025 (the first listed expiry after the decision; ATM implied volatility 29%). The stock closed -0.2% at the first close across the decision and +1.4% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.

Decision facts

FDA decision date2025-02-12
DrugADCETRIS (brentuximab vedotin) with lenalidomide and rituximab - (ECHELON-3)
IndicationRelapsed/refractory diffuse large B-cell lymphoma (DLBCL)
Outcome✓ Approvedprimary-sourced
Decision-day move-0.2%
T-120 run-up (low→high)+2.0% ($24.8→$29.67)
Market-cap tierLarge
Cohort decision-day move (history)1.0% median (n=835)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

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Questions

Was ADCETRIS (brentuximab vedotin) with lenalidomide and rituximab - (ECHE approved by the FDA?

Yes. The FDA approved the application for ADCETRIS (brentuximab vedotin) with lenalidomide and rituximab - (ECHE on February 12, 2025. The primary source is linked on this page.

What was ADCETRIS (brentuximab vedotin) with lenalidomide and rituximab - (ECHE under FDA review for?

The application covered Relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The FDA approved the application on February 12, 2025.

How did PFE stock react to the FDA decision?

On the decision day PFE moved -0.2%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.